VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
feeling faint; breathless; Palpitations; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110170825392900-KQSJO, Safety Report Unique Identifier GB-MHRA-ADR 26085258. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF828), via an unspecified route of administration on 15Oct2021 (at the age of 14 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included peanut and sesame allergy. Patient has not had symptoms associated with COVID-19. Concomitant medications were not reported. The patient previously took epinephrine (EPIPEN). The patient experienced feeling faint and breathless on an unspecified date. He had 4 occurrences and one so severe for which he visited ER for electrocardiogram (ECG) trace. The patient experienced palpitations on 15Oct2021. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the palpitations was not recovered while of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||28 October 2021|
|LAB_DATA:||Test Name: ecg; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test|
|HISTORY:||Medical History/Concurrent Conditions: Food allergy (Peanut and sesame allergy)|
|TODAYS_DATE:||28 October 2021|